Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGermans Trias i Pujol Hospital

About this trial

Total knee replacement surgery is associated with significant pain in the immediate postoperative period, especially in movement. In turn, this is associated with more subsequent chronic pain.

There are multiple options and the tendency is to perform increasingly distal nerve blocks to minimize limb weakness and thus allow early rehabilitation. In 2012, in an oral communication, Sanjay Sinha described a new nerve block called iPACK ("Interspace between the Popliteal Artery and the Capsule of the posterior Knee"). There are few studies on the efficacy of such a blockade so far, but none comparing the groups saphene + sciatic blocks vs. saphene + iPACK blocks.

Therefore, this study aims to provide more information on the effectiveness this nerve blocks, in total knee replacement, in terms of analgesia and motor function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with osteoarthritis scheduled for total primary knee arthroplasty with same surgeons

Locoregional anesthesia

Age equal to or greater than 18 years

Consent to participate in the study

Disqualifiers

Age under 18 years old

General anesthesia

Allergy to local anesthetics

Severe kidney failure (Cr ≥ 2mg / dL)

Trial design

Design model

Parallel

Treatments tested in this trial

  • IPACK block with Bupivacaine 0.25% with adrenaline

    Drug

    The iPACK in performed in the popliteal fossa about 1 finger breath above the patella, ecoguided. That aims to anesthetize the articular branches to the posterior aspect of the knee in the popliteal region.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Echo-guided IPACK blockExperimental treatment 1 intervention
Group B: Echo-guided sciatic blockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain at rest

Measured by the numerical visual scale at 6 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.

Time frame
6 hours after surgery
2

Pain at rest

Measured by the numerical visual scale at 24 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.

Time frame
24 hours after surgery
3

Pain at rest

Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.

Time frame
48 hours after surgery
4

Pain at movement

Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.

Time frame
6 hours after surgery

Secondary outcomes

1

Opioids dose

Measured in milligrams of intravenous morphine hydrochloride daily.

Time frame
6 hours after surgery
2

Opioids dose

Measured in milligrams of intravenous morphine hydrochloride daily.

Time frame
24 hours after surgery
3

Opioids dose

Measured in milligrams of intravenous morphine hydrochloride daily.

Time frame
48 hours after surgery
4

Discharge days

Time to discharge measured in days

Time frame
Days

Other outcomes

Sponsors and contacts

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